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funding lost
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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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The purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the negative effects of nicotine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo |
|
| Atomoxetine | Experimental | atomoxetine (40 mg/day) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Effects Questionnaire | Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects. | Day 5 |
| Nicotine Effects Questionnaire | Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects. | Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiologic Studies Depression (CES-D) scale | The Center for Epidemiologic Studies Depression (CES-D) scale is a 20-item self-report measure of depressive symptoms. The range of scores is from 0 to 60, with higher scores reflecting increased depressive symptoms 41. The CES-D does not heavily depend on pathological items compared with other scales such as the Beck Depression Inventory and does not define clinical depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Arias, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Haven Veterans Affairs | West Haven | Connecticut | 06515 | United States |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
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| Day 5 |
| Positive and Negative Affect Schedule (PANAS ) | Positive and Negative Affect Schedule (PANAS ) is a 20-item scale that assesses both negative and positive affective states. Subjects rate adjectives describing affective states on a scale of 1 to 5 using a specified time period (e.g., now, today, past week etc.). Scores are then added up to generate negative and positive scale scores. | Day 5 |
| The Profile of Mood States (POMS) | The Profile of Mood States (POMS) is a 72-item questionnaire which consists of adjectives commonly used to describe momentary mood states. It has been found to be sensitive to the mood-altering effects of drugs including nicotine. POMS has a 5-point objective rating scale (0=not at all to 5=extremely). There are eight mood states that this scale measures: (1) Anger, (2) Anxiety, (3) Confusion, (4) Depression, (5) Elation, (6) Fatigue, (7) Friendliness and (8) Vigor. POMS will be used during each session to measure effects of atomoxetine or nicotine on mood. | Day 5 |
| Center for Epidemiologic Studies Depression (CES-D) scale | The Center for Epidemiologic Studies Depression (CES-D) scale is a 20-item self-report measure of depressive symptoms. The range of scores is from 0 to 60, with higher scores reflecting increased depressive symptoms 41. The CES-D does not heavily depend on pathological items compared with other scales such as the Beck Depression Inventory and does not define clinical depression. | Day 17 |
| Positive and Negative Affect Schedule (PANAS ) | Positive and Negative Affect Schedule (PANAS ) is a 20-item scale that assesses both negative and positive affective states 44. Subjects rate adjectives describing affective states on a scale of 1 to 5 using a specified time period (e.g., now, today, past week etc.). Scores are then added up to generate negative and positive scale scores. | Day 17 |
| The Profile of Mood States (POMS) | The Profile of Mood States (POMS) is a 72-item questionnaire which consists of adjectives commonly used to describe momentary mood states. It has been found to be sensitive to the mood-altering effects of drugs including nicotine. POMS has a 5-point objective rating scale (0=not at all to 5=extremely). There are eight mood states that this scale measures: (1) Anger, (2) Anxiety, (3) Confusion, (4) Depression, (5) Elation, (6) Fatigue, (7) Friendliness and (8) Vigor. POMS will be used during each session to measure effects of atomoxetine or nicotine on mood. | Day 17 |
| Symptom Checklist Form (SCF) | In order to monitor adverse events from the study medications, SCF will be administered before and after each session. SCF is a locally developed symptom checklist that includes possible side effects of study medications with each symptom being scored 1-5. | Day 5 |
| Symptom Checklist Form (SCF) | In order to monitor adverse events from the study medications, SCF will be administered before and after each session. SCF is a locally developed symptom checklist that includes possible side effects of study medications with each symptom being scored 1-5. | Day 17 |
| Nicotine Withdrawal Symptom Checklist (NWSC) | Smokers will be asked to rate several nicotine withdrawal symptoms on a likert scale visual analogue. There are 12 items responses range from 0, "not at all" to 3 "extremely". | Day 5 |
| Nicotine Withdrawal Symptom Checklist (NWSC) | Smokers will be asked to rate several nicotine withdrawal symptoms on a likert scale visual analogue. There are 12 items responses range from 0, "not at all" to 3 "extremely". | Day 17 |